Duns Number:656303754
Device Description: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resis EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space
Catalog Number
-
Brand Name
EpiFaith Syringe
Version/Model Number
FM-01SLR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192421,K192421,K192421,K192421,K192421,K192421
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
92611675-a725-403f-8918-0bdd37a5261b
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
July 07, 2020
Package DI Number
44719875599017
Quantity per Package
50
Contains DI Package
34719875599010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box